8 Sources of evidence considered by the Committee

8 Sources of evidence considered by the Committee

A. The Evidence Review Group (ERG) report for this appraisal was prepared by BMJ‑TAG:

  • Edwards S, Wakefield V, Thurgar , et al., dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism, August 2014

B. The following organisations accepted the invitation to participate in this appraisal as consultees and commentators. They were invited to comment on the draft scope. Organisations listed in I were also invited to make written submissions. Organisations listed in II and III had the opportunity to give their expert views. Organisations listed in I, II and III also have the opportunity to appeal against the final appraisal determination.

I. Company:

  • Boehringer Ingelheim (dabigatran etexilate)

II. Professional/specialist and patient/carer groups:

  • AntiCoagulation Europe(ACE)

  • British Cardiovascular Society

  • British Society for Haematology

  • Clinical Leaders of Thrombosis (CLOT)

  • Lifeblood: The Thrombosis Charity

  • Royal College of Nursing

  • Royal College of Pathologists

  • Royal College of Physicians

  • United Kingdom Clinical Pharmacy Association

III. Other consultees:

  • Department of Health

  • NHS England

  • Welsh Government

IV. Commentator organisations (did not provide written evidence and without the right of appeal):

  • Bayer (rivaroxaban)

  • BMJ‑TAG

  • Department of Health and Social Services and Public Safety, Northern Ireland (DHSSPSNI)

  • Healthcare Improvement Scotland

  • LEO Pharma (tinzaparin)

  • National Institute for Health Research Technology Assessment Programme

  • Sanofi (enoxaparin)

C. The following individuals were selected from clinical expert and patient expert nominations from the consultees and commentators. They gave their expert personal view on dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism by attending the initial Committee discussion and providing written evidence to the Committee.

  • Dr Peter MacCallum, Senior Lecturer and Honorary Consultant Haematologist, nominated by organisation representing British Cardiovascular Society – clinical expert

  • Ms Diane Eaton, Project Manager for ACE, nominated by organisation representing AntiCoagulation Europe(ACE) – patient expert

E. Representatives from the following company attended Committee meetings. They contributed only when asked by the Committee chair to clarify specific issues and comment on factual accuracy.

  • Boehringer Ingelheim

  • National Institute for Health and Care Excellence (NICE)